Malaria Vaccine Trials in Mali

描述（由申请人提供）：疟疾是热带地区主要的寄生虫感染性疾病。非洲儿童承受的负担最重，每年有200多万儿童死于这种可怕的疾病。疫苗开发的关键途径需要在美国进行安全性（1A期）疫苗试验，然后在疟疾流行地区进行安全性和有效性（1B/ 2B期）疫苗试验。 两个项目是围绕开发安全有效的疟疾疫苗以预防非洲儿童因恶性疟疾而患病和死亡的中心主题组织的。项目1将进行疟疾候选疫苗的干预性临床试验，项目2将分析项目1的样本，以解决为疫苗开发和测试过程提供信息的重要问题。行政和生物统计核心将支持这两个项目。我们的另一个主要目标是为美国和马里科学家提供研究经验，加强美国和马里研究人员之间已经很强的联系，以提高马里巴马科大学的独立研究能力。 大多数拟议的研究将在马里的班迪亚加拉疟疾项目临床试验地点和巴马科大学疟疾研究和培训中心进行。美国和马里的研究人员将在研究的设计、实施、监测和管理方面密切合作。

DESCRIPTION (provided by applicant): Malaria is the leading parasitic infectious disease in the tropics. The heaviest burden is borne by children in Africa, where more than 2 million succumb to this dreaded disease every year. The critical pathway for vaccine development requires the conduct of safety (Phase 1A) vaccine trials in the United States, followed by safety and efficacy (Phase1B/ 2B) vaccine trials at sites where malaria transmission is endemic. Two projects are organized around the central theme of developing a safe and effective malaria vaccine to prevent disease and death due to falciparum malaria in African children. Interventional clinical trials of a malaria vaccine candidate will be conducted in Project 1, and samples from Project 1 will be analyzed in Project 2 to address important questions that will inform the vaccine development and testing process. Administrative and biostatistical cores will support both projects. Our other main objective is to provide research experience for U.S. and Malian scientists and to strengthen the already strong linkages between U.S. and Malian investigators to enhance the independent research capacity of the University of Bamako, Mali. The majority of the proposed research will be conducted in Mali, at the Bandiagara Malaria Project clinical trials site and at the Malaria Research and Training Center at the University of Bamako. The U.S. and Malian investigators will collaborate closely in the design, implementation, monitoring, and management of the research.